Trial Outcomes & Findings for A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to MCV4, Tdap and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 10 Through 12 Years of Age (NCT NCT01461980)

NCT ID: NCT01461980

Last Updated: 2018-12-20

Results Overview

Antibody GMCs of 2 antigens of diphtheria and tetanus toxoid were computed in International Units per milliliter (IU/mL) along with corresponding 2-sided 95 percent (%) confidence intervals (CIs). Here, 'number of participants analyzed' signifies participants with valid and determinate assay results for given antigen.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

2648 participants

Primary outcome timeframe

1 Month after Vaccination 1

Results posted on

2018-12-20

Participant Flow

A total of 2648 participants were enrolled in this study. Of these, 19 participants were randomized but did not receive study vaccination.

Participant milestones

Participant milestones
Measure	MCV4+Tdap+rLP2086 Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.	MCV4+Tdap+Saline Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.	Saline+Saline+rLP2086 Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
Overall Study STARTED	888	878	882
Overall Study Vaccination 1	884	870	875
Overall Study Vaccination 2	802	819	799
Overall Study Vaccination 3	757	777	748
Overall Study COMPLETED	722	733	717
Overall Study NOT COMPLETED	166	145	165

Reasons for withdrawal

Reasons for withdrawal
Measure	MCV4+Tdap+rLP2086 Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.	MCV4+Tdap+Saline Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.	Saline+Saline+rLP2086 Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
Overall Study Other	9	8	6
Overall Study Medication error	7	5	6
Overall Study Adverse Event	12	5	6
Overall Study Protocol Violation	12	19	16
Overall Study No longer meets eligibility criteria	18	9	19
Overall Study Lost to Follow-up	52	53	51
Overall Study No longer willing to participate	52	38	54
Overall Study Randomized but not vaccinated	4	8	7

Baseline Characteristics

A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to MCV4, Tdap and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 10 Through 12 Years of Age

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MCV4+Tdap+rLP2086 n=888 Participants Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.	MCV4+Tdap+Saline n=878 Participants Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.	Saline+Saline+rLP2086 n=882 Participants Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.	Total n=2648 Participants Total of all reporting groups
Age, Continuous	10.6 Years STANDARD_DEVIATION 0.70 • n=5 Participants	10.6 Years STANDARD_DEVIATION 0.69 • n=7 Participants	10.6 Years STANDARD_DEVIATION 0.67 • n=5 Participants	10.6 Years STANDARD_DEVIATION 0.69 • n=4 Participants
Sex: Female, Male Female	454 Participants n=5 Participants	427 Participants n=7 Participants	417 Participants n=5 Participants	1298 Participants n=4 Participants
Sex: Female, Male Male	434 Participants n=5 Participants	451 Participants n=7 Participants	465 Participants n=5 Participants	1350 Participants n=4 Participants

PRIMARY outcome

Timeframe: 1 Month after Vaccination 1

Population: Post vaccination 1 evaluable immunogenicity population: eligible participants randomized to Group 1 or 2, received scheduled investigational product, had pre and post vaccination blood drawn at pre-specified time points, had valid, determinate assay results for proposed analysis, received no prohibited vaccines, no other major protocol violations.

Outcome measures

Outcome measures
Measure	MCV4+Tdap+rLP2086 n=778 Participants Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.	MCV4+Tdap+Saline n=780 Participants Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.	Saline+Saline+rLP2086 Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus Antigens Diphtheria	9.3 IU/mL Interval 8.67 to 9.92	9.8 IU/mL Interval 9.23 to 10.51	—
Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus Antigens Tetanus	9.4 IU/mL Interval 8.95 to 9.98	10.3 IU/mL Interval 9.75 to 10.85	—

PRIMARY outcome

Timeframe: 1 Month after Vaccination 1

Population: Post vaccination 1 evaluable immunogenicity population. Here, 'number of participants analyzed' signifies participants with valid and determinate assay results for given antigen.

Antibody GMCs of 4 acellular pertussis antigens (pertussis toxoid, pertussis filamentous hemagglutinin, pertussis pertactin and pertussis fimbrial agglutinogens types 2+3) were computed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL) along with corresponding 2-sided 95% CIs.

Outcome measures

Outcome measures
Measure	MCV4+Tdap+rLP2086 n=778 Participants Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.	MCV4+Tdap+Saline n=780 Participants Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.	Saline+Saline+rLP2086 Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
Geometric Mean Concentrations (GMC) for Acellular Pertussis Antigens Pertussis toxoid	13.2 EU/mL Interval 12.35 to 14.14	14.2 EU/mL Interval 13.28 to 15.2	—
Geometric Mean Concentrations (GMC) for Acellular Pertussis Antigens Pertussis filamentous hemagglutinin	112.0 EU/mL Interval 106.15 to 118.14	122.9 EU/mL Interval 116.42 to 129.84	—
Geometric Mean Concentrations (GMC) for Acellular Pertussis Antigens Pertussis pertactin	202.0 EU/mL Interval 187.77 to 217.25	228.9 EU/mL Interval 212.72 to 246.35	—
Geometric Mean Concentrations (GMC) for Acellular Pertussis Antigens Pertussis fimbrial agglutinogens types 2+3	138.1 EU/mL Interval 121.2 to 157.33	154.2 EU/mL Interval 135.3 to 175.79	—

PRIMARY outcome

Timeframe: 1 Month after Vaccination 1

Population: Post vaccination 1 evaluable immunogenicity population. Here, 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.

Antibody GMTs of 4 MCV4 antigens (serogroup A, serogroup C, serogroup Y and serogroup W-135) were computed along with corresponding 2-sided 95% CIs.

Outcome measures

Outcome measures
Measure	MCV4+Tdap+rLP2086 n=779 Participants Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.	MCV4+Tdap+Saline n=781 Participants Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.	Saline+Saline+rLP2086 Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
Geometric Mean Titer (GMT) for Meningococcal Conjugate Vaccine (MCV4) Antigens Serogroup C (N=768, 767)	1679.2 titer Interval 1539.63 to 1831.38	1650.2 titer Interval 1519.01 to 1792.65	—
Geometric Mean Titer (GMT) for Meningococcal Conjugate Vaccine (MCV4) Antigens Serogroup A (N=763, 772)	4647.3 titer Interval 4317.66 to 5002.09	5113.0 titer Interval 4748.73 to 5505.17	—
Geometric Mean Titer (GMT) for Meningococcal Conjugate Vaccine (MCV4) Antigens Serogroup Y (N=771, 770)	2212.6 titer Interval 2056.08 to 2381.08	2244.9 titer Interval 2088.7 to 2412.89	—
Geometric Mean Titer (GMT) for Meningococcal Conjugate Vaccine (MCV4) Antigens Serogroup W-135 (N=751, 765)	5925.1 titer Interval 5469.77 to 6418.33	6367.9 titer Interval 5872.68 to 6904.88	—

PRIMARY outcome

Timeframe: 1 Month after Vaccination 3

Population: Post vaccination 3 evaluable immunogenicity population: eligible participants randomized to Group 1 or 3, received scheduled investigational product, had pre and post vaccination blood drawn at pre-specified time points, had valid, determinate assay results for proposed analysis, received no prohibited vaccines, no other major protocol violations.

Antibody hSBA GMTs of primary strain PMB80 \[A22\] and PMB2948 \[B24\] were computed along with corresponding 2-sided 95% CIs. hSBA titers from the 2 primary strains were logarithmically transformed for analysis. Here, 'number of participants analyzed' signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.

Outcome measures

Outcome measures
Measure	MCV4+Tdap+rLP2086 n=683 Participants Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.	MCV4+Tdap+Saline n=679 Participants Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.	Saline+Saline+rLP2086 Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] 1 Month After Vaccination 3 PMB80 [A22] (N=679, 674)	45.9 titer Interval 42.74 to 49.35	49.7 titer Interval 46.43 to 53.3	—
Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] 1 Month After Vaccination 3 PMB2948 [B24] (N=670, 656)	24.8 titer Interval 23.11 to 26.58	27.4 titer Interval 25.58 to 29.41	—

SECONDARY outcome

Timeframe: 1 Month after Vaccination 1

Population: Post vaccination 1 evaluable immunogenicity population. Here, 'number of participants analyzed' signifies participants with valid, determinate assay results for given antigen at specified time point and baseline. 'N' signifies number of participants with seroresponse.

Seroconversion rate for Tdap antigens was defined as greater than or equal to (\>=) 4-, 2-fold rise in antibody concentration, if prevaccination antibody concentration was less than or equal to (\<=), greater than (\>) cutoff value, respectively. For MCV4 antigens \>=4-fold rise on serum bactericidal assay using rabbit complement (rSBA) titers if baseline value \>= lower limit of quantitation (LLOQ), postdose rSBA titers \>=2×LLOQ if baseline value was less than (\<) LLOQ. Cutoff value =0.1 IU/mL for diphtheria and tetanus, 0.9,2.9,3.0,10.6 EU/mL for pertussis toxoid, filamentous hemagglutinin, pertactin, fimbriae agglutinogens types 2 + 3, respectively.

Outcome measures

Outcome measures
Measure	MCV4+Tdap+rLP2086 n=779 Participants Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.	MCV4+Tdap+Saline n=781 Participants Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.	Saline+Saline+rLP2086 Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens Diphtheria (N=774, 780)	98.6 percentage of participants Interval 97.5 to 99.3	98.3 percentage of participants Interval 97.2 to 99.1	—
Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens Tetanus (N=774, 780)	97.7 percentage of participants Interval 96.3 to 98.6	97.4 percentage of participants Interval 96.1 to 98.4	—
Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens Pertussis toxoid (N=774, 780)	68.1 percentage of participants Interval 64.7 to 71.4	72.7 percentage of participants Interval 69.4 to 75.8	—
Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens Pertussis filamentous hemagglutinin (N=774, 780)	85.3 percentage of participants Interval 82.6 to 87.7	89.2 percentage of participants Interval 86.8 to 91.3	—
Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens Pertussis pertactin (N=774, 780)	96.0 percentage of participants Interval 94.4 to 97.3	96.2 percentage of participants Interval 94.6 to 97.4	—
Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens Pertussis fimbriae AG types 2+3 (N=774, 780)	79.5 percentage of participants Interval 76.4 to 82.3	81.9 percentage of participants Interval 79.0 to 84.6	—
Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens Serogroup A (N=712, 736)	85.4 percentage of participants Interval 82.6 to 87.9	88.6 percentage of participants Interval 86.1 to 90.8	—
Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens Serogroup C (N=738, 742)	89.3 percentage of participants Interval 86.8 to 91.4	88.9 percentage of participants Interval 86.5 to 91.1	—
Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens Serogroup Y (N=754, 753)	90.5 percentage of participants Interval 88.1 to 92.5	93.6 percentage of participants Interval 91.6 to 95.3	—
Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens Serogroup W-135 (N=729, 752)	97.1 percentage of participants Interval 95.6 to 98.2	97.2 percentage of participants Interval 95.8 to 98.3	—

SECONDARY outcome

Timeframe: 1 Month after Vaccination 1

Population: Post vaccination 1 evaluable immunogenicity population. Here, 'number of participants analyzed' signifies participants with valid, determinate assay results for given antigen.

Participants with antibody concentration level of greater than or equal to 1.0 IU/mL for diphtheria and tetanus antigens were computed along with corresponding 2-sided 95% CIs.

Outcome measures

Outcome measures
Measure	MCV4+Tdap+rLP2086 n=778 Participants Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.	MCV4+Tdap+Saline n=780 Participants Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.	Saline+Saline+rLP2086 Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
Percentage of Participants Achieving Predefined Antibody Level for Diphtheria and Tetanus Antigens Tetanus	99.1 percentage of participants Interval 98.2 to 99.6	99.0 percentage of participants Interval 98.0 to 99.6	—
Percentage of Participants Achieving Predefined Antibody Level for Diphtheria and Tetanus Antigens Diphtheria	98.1 percentage of participants Interval 96.8 to 98.9	99.0 percentage of participants Interval 98.0 to 99.6	—

SECONDARY outcome

Timeframe: Before Vaccination 1, 1 Month after Vaccination (Vac) 2

Population: Post vaccination 3 evaluable immunogenicity population. Here, 'number of participants analyzed' signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.

Antibody hSBA of primary strain PMB80 \[A22\] and PMB2948 \[B24\] were computed along with corresponding 2-sided 95% CIs. hSBA titers from the 2 primary strains were logarithmically transformed for analysis.

Outcome measures

Outcome measures
Measure	MCV4+Tdap+rLP2086 n=683 Participants Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.	MCV4+Tdap+Saline n=679 Participants Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.	Saline+Saline+rLP2086 Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] Before Vaccination 1 and 1 Month After Vaccination 2 Before Vaccination 1: PMB80 [A22] (N=677, 677)	8.5 titer Interval 8.28 to 8.64	8.6 titer Interval 8.39 to 8.84	—
Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] Before Vaccination 1 and 1 Month After Vaccination 2 Before Vaccination 1: PMB2948 [B24] (N=677, 676)	4.1 titer Interval 4.04 to 4.19	4.2 titer Interval 4.1 to 4.27	—
Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] Before Vaccination 1 and 1 Month After Vaccination 2 1 Month after Vac 2: PMB80 [A22] (N=669, 665)	23.7 titer Interval 22.1 to 25.4	23.8 titer Interval 22.14 to 25.54	—
Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] Before Vaccination 1 and 1 Month After Vaccination 2 1 Month after Vac 2: PMB2948 [B24] (N=656, 650)	12.0 titer Interval 11.12 to 12.99	13.0 titer Interval 12.03 to 14.13	—

SECONDARY outcome

Timeframe: Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3

Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95% CIs. LLOQ was 1:16 for PMB80 \[A22\] and 1:8 for PMB2948 \[B24\].

Outcome measures

Outcome measures
Measure	MCV4+Tdap+rLP2086 n=683 Participants Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.	MCV4+Tdap+Saline n=679 Participants Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.	Saline+Saline+rLP2086 Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ) Before Vaccination 1: PMB80[A22] 1:16 (N=677, 677)	4.4 percentage of participants Interval 3.0 to 6.3	5.6 percentage of participants Interval 4.0 to 7.6	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ) 1 month after Vac 2: PMB80[A22] 1:16 (N= 669, 665)	68.0 percentage of participants Interval 64.3 to 71.5	68.0 percentage of participants Interval 64.3 to 71.5	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ) 1 month after Vac 3: PMB80 [A22] 1:16 (N=679, 674)	87.5 percentage of participants Interval 84.8 to 89.9	91.4 percentage of participants Interval 89.0 to 93.4	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ) Before Vaccination 1: PMB2948[B24] 1:8 (N=677,676)	1.6 percentage of participants Interval 0.8 to 2.9	3.4 percentage of participants Interval 2.2 to 5.1	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ) 1 month after Vac 2: PMB2948[B24] 1:8 (N=656, 650)	62.3 percentage of participants Interval 58.5 to 66.1	66.0 percentage of participants Interval 62.2 to 69.6	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ) 1 month after Vac 3: PMB2948[B24] 1:8 (N=670, 656)	90.0 percentage of participants Interval 87.5 to 92.2	92.7 percentage of participants Interval 90.4 to 94.6	—

SECONDARY outcome

Timeframe: Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3

Antibody hSBA of primary strain PMB80 \[A22\] and PMB2948 \[B24\] with hSBA titers \>=1:4, \>=1:8, \>=1:16, \>=1:32, \>=1:64, and \>=1:128 were computed along with corresponding 2-sided 95% CIs.

Outcome measures

Outcome measures
Measure	MCV4+Tdap+rLP2086 n=683 Participants Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.	MCV4+Tdap+Saline n=679 Participants Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.	Saline+Saline+rLP2086 Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level Before Vaccination 1: PMB80[A22] 1:4 (N=677,677)	6.9 percentage of participants Interval 5.1 to 9.1	7.5 percentage of participants Interval 5.7 to 9.8	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level 1 month after Vac 2: PMB80[A22] 1:4 (N=669, 665)	68.2 percentage of participants Interval 64.5 to 71.7	68.6 percentage of participants Interval 64.9 to 72.1	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level 1 month after Vac 3: PMB80[A22] 1:4 (N=679, 674)	87.8 percentage of participants Interval 85.1 to 90.1	91.7 percentage of participants Interval 89.3 to 93.7	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level Before Vaccination 1: PMB80[A22] 1:8 (N=677, 677)	5.0 percentage of participants Interval 3.5 to 6.9	6.4 percentage of participants Interval 4.6 to 8.5	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level 1 month after Vac 2: PMB80[A22] 1:8 (N=669, 665)	68.2 percentage of participants Interval 64.5 to 71.7	68.1 percentage of participants Interval 64.4 to 71.7	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level 1 month after Vac 3: PMB80[A22] 1:8 (N=679, 674)	87.6 percentage of participants Interval 84.9 to 90.0	91.5 percentage of participants Interval 89.2 to 93.5	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level Before Vaccination 1: PMB80[A22] 1:32 (N=677, 677)	2.7 percentage of participants Interval 1.6 to 4.2	3.2 percentage of participants Interval 2.0 to 4.9	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level 1 month after Vac 2: PMB80[A22] 1:32 (N=669, 665)	55.0 percentage of participants Interval 51.1 to 58.8	54.4 percentage of participants Interval 50.6 to 58.3	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level 1 month after Vac 3: PMB80[A22] 1:32 (N=679, 674)	81.3 percentage of participants Interval 78.2 to 84.2	84.7 percentage of participants Interval 81.8 to 87.4	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level Before Vaccination 1: PMB80[A22] 1:64 (N=677,677)	0.7 percentage of participants Interval 0.2 to 1.7	1.0 percentage of participants Interval 0.4 to 2.1	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level 1 month after Vac 2: PMB80[A22] 1:64 (N= 669, 665)	25.6 percentage of participants Interval 22.3 to 29.0	25.0 percentage of participants Interval 21.7 to 28.4	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level 1 month after Vac 3: PMB80[A22] 1:64 (N=679, 674)	52.7 percentage of participants Interval 48.9 to 56.5	55.6 percentage of participants Interval 51.8 to 59.4	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level Before Vaccination 1: PMB80[A22] 1:128 (N=677,677)	0.1 percentage of participants Interval 0.0 to 0.8	0.4 percentage of participants Interval 0.1 to 1.3	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level 1 month after Vac 2: PMB80[A22] 1:128 (N=669, 665)	6.9 percentage of participants Interval 5.1 to 9.1	7.5 percentage of participants Interval 5.6 to 9.8	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level 1 month after Vac 3: PMB80[A22] 1:128 (N=679, 674)	23.6 percentage of participants Interval 20.4 to 26.9	23.3 percentage of participants Interval 20.2 to 26.7	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level Before Vaccination 1: PMB2948[B24] 1:4 (N=677,676)	2.1 percentage of participants Interval 1.1 to 3.4	3.7 percentage of participants Interval 2.4 to 5.4	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level 1 month after Vac 2: PMB2948[B24] 1:4 (N=656, 650)	64.8 percentage of participants Interval 61.0 to 68.4	68.2 percentage of participants Interval 64.4 to 71.7	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level 1 month after Vac 3: PMB2948[B24] 1:4 (N=670, 656)	90.7 percentage of participants Interval 88.3 to 92.8	93.1 percentage of participants Interval 90.9 to 95.0	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level Before Vaccination 1: PMB2948[B24] 1:16(N=677,676)	1.5 percentage of participants Interval 0.7 to 2.7	2.1 percentage of participants Interval 1.1 to 3.5	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level 1 month after Vac 2: PMB2948[B24] 1:16(N=656,650)	57.6 percentage of participants Interval 53.7 to 61.4	60.3 percentage of participants Interval 56.4 to 64.1	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level 1 month after Vac 3: PMB2948[B24] 1:16(N=670,656)	86.7 percentage of participants Interval 83.9 to 89.2	88.9 percentage of participants Interval 86.2 to 91.2	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level Before Vaccination 1: PMB2948[B24] 1:32(N=677,676)	0.4 percentage of participants Interval 0.1 to 1.3	0.6 percentage of participants Interval 0.2 to 1.5	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level 1 month after Vac 2: PMB2948[B24] 1:32(N=656,650)	26.2 percentage of participants Interval 22.9 to 29.8	28.2 percentage of participants Interval 24.7 to 31.8	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level 1 month after Vac 3: PMB2948[B24] 1:32(N=670, 656)	55.1 percentage of participants Interval 51.2 to 58.9	60.7 percentage of participants Interval 56.8 to 64.4	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level Before Vaccination 1:PMB2948[B24] 1:64(N= 677,676)	0.4 percentage of participants Interval 0.1 to 1.3	0.3 percentage of participants Interval 0.0 to 1.1	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level 1 month after Vac 2: PMB2948[B24] 1:64 (N=656,650)	8.7 percentage of participants Interval 6.6 to 11.1	10.3 percentage of participants Interval 8.1 to 12.9	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level 1 month after Vac 3: PMB2948[B24] 1:64 (N=670,656)	22.5 percentage of participants Interval 19.4 to 25.9	24.1 percentage of participants Interval 20.9 to 27.5	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level Before Vaccination 1:PMB2948[B24] 1:128(N=677,676)	0.1 percentage of participants Interval 0.0 to 0.8	0.1 percentage of participants Interval 0.0 to 0.8	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level 1 month after Vac 2: PMB2948[B24] 1:128(N=656,650)	2.4 percentage of participants Interval 1.4 to 3.9	3.4 percentage of participants Interval 2.1 to 5.1	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level 1 month after Vac 3: PMB2948[B24] 1:128(N=670,656)	6.6 percentage of participants Interval 4.8 to 8.7	7.8 percentage of participants Interval 5.8 to 10.1	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Before Vaccination 1, 1 Month after Vaccination 1

Population: Post vaccination 1 evaluable immunogenicity population.

IgG GMCs of 4 MCV4 antigens (serogroup A, serogroup C, serogroup Y and serogroup W-135) of participants were computed along with corresponding 2-sided 95% CIs. CIs were back transformations of confidence levels based on Student t distribution for mean logarithm of titers.

Outcome measures

Outcome measures
Measure	MCV4+Tdap+rLP2086 n=779 Participants Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.	MCV4+Tdap+Saline n=781 Participants Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.	Saline+Saline+rLP2086 Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
Immunogloblulin G (IgG) Measured by GMC Before Vaccination 1: Serogroup A	0.17 microgram per milliliter (mcg/mL) Interval 0.16 to 0.19	0.15 microgram per milliliter (mcg/mL) Interval 0.14 to 0.17	—
Immunogloblulin G (IgG) Measured by GMC 1 Month after Vaccination 1: Serogroup A	11.42 microgram per milliliter (mcg/mL) Interval 10.3 to 12.65	11.38 microgram per milliliter (mcg/mL) Interval 10.21 to 12.67	—
Immunogloblulin G (IgG) Measured by GMC Before Vaccination 1: Serogroup C	0.11 microgram per milliliter (mcg/mL) Interval 0.1 to 0.12	0.11 microgram per milliliter (mcg/mL) Interval 0.1 to 0.12	—
Immunogloblulin G (IgG) Measured by GMC 1 Month after Vaccination 1: Serogroup C	5.59 microgram per milliliter (mcg/mL) Interval 4.9 to 6.39	5.47 microgram per milliliter (mcg/mL) Interval 4.79 to 6.23	—
Immunogloblulin G (IgG) Measured by GMC Before Vaccination 1: Serogroup Y	0.14 microgram per milliliter (mcg/mL) Interval 0.13 to 0.14	0.13 microgram per milliliter (mcg/mL) Interval 0.13 to 0.14	—
Immunogloblulin G (IgG) Measured by GMC 1 Month after Vaccination 1: Serogroup Y	2.49 microgram per milliliter (mcg/mL) Interval 2.22 to 2.79	2.14 microgram per milliliter (mcg/mL) Interval 1.92 to 2.39	—
Immunogloblulin G (IgG) Measured by GMC Before Vaccination 1: Serogroup W-135	0.13 microgram per milliliter (mcg/mL) Interval 0.13 to 0.14	0.13 microgram per milliliter (mcg/mL) Interval 0.13 to 0.14	—
Immunogloblulin G (IgG) Measured by GMC 1 Month after Vaccination 1: Serogroup W-135	1.79 microgram per milliliter (mcg/mL) Interval 1.59 to 2.01	1.84 microgram per milliliter (mcg/mL) Interval 1.62 to 2.09	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 Month after Vaccination (Vac) 2, 3

Population: Post vaccination 3 evaluable immunogenicity population. Here, 'number of participants analyzed' signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate hSBA titers for the given strain at both the specified time point and baseline.

Outcome measures

Outcome measures
Measure	MCV4+Tdap+rLP2086 n=683 Participants Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.	MCV4+Tdap+Saline n=679 Participants Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.	Saline+Saline+rLP2086 Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
Percentage of Participants Achieving at Least 4-Fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level 1 month after Vac 2 : PMB80 [A22] (N=663, 663)	64.3 percentage of participants Interval 60.5 to 67.9	63.7 percentage of participants Interval 59.9 to 67.3	—
Percentage of Participants Achieving at Least 4-Fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level 1 month after Vac 3 : PMB80 [A22] (N=673, 672)	84.0 percentage of participants Interval 81.0 to 86.6	88.7 percentage of participants Interval 86.0 to 91.0	—
Percentage of Participants Achieving at Least 4-Fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level 1 month after Vac 2 : PMB2948 [B24] (N=650, 647)	56.3 percentage of participants Interval 52.4 to 60.2	58.4 percentage of participants Interval 54.5 to 62.3	—
Percentage of Participants Achieving at Least 4-Fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level 1 month after Vac 3 : PMB2948 [B24] (N=664, 653)	85.7 percentage of participants Interval 82.8 to 88.3	87.7 percentage of participants Interval 85.0 to 90.2	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Vaccination phase (baseline up to 1 month after Vaccination 3); Follow-up phase (from 1 month up to 6 months after Vaccination 3)

Population: Safety population included all participants who received at least 1 dose of the investigational product and had safety information available. 'N' signifies participants evaluable for this measure during specified time period.

An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.

Outcome measures

Outcome measures
Measure	MCV4+Tdap+rLP2086 n=883 Participants Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.	MCV4+Tdap+Saline n=870 Participants Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.	Saline+Saline+rLP2086 n=875 Participants Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
Percentage of Participants With at Least One Adverse Event (AE) Vaccination phase: Adverse Events (N=883,870,875)	42.9 percentage of participants	42.6 percentage of participants	46.2 percentage of participants
Percentage of Participants With at Least One Adverse Event (AE) Follow-up phase: Adverse Events (N=777,776,771)	1.0 percentage of participants	0.5 percentage of participants	1.3 percentage of participants

Adverse Events

MCV4+Tdap+rLP2086

Serious events: 15 serious events

Other events: 277 other events

Deaths: 0 deaths

MCV4+Tdap+Saline

Serious events: 9 serious events

Other events: 260 other events

Deaths: 0 deaths

Saline+Saline+rLP2086

Serious events: 11 serious events

Other events: 292 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	MCV4+Tdap+rLP2086 n=883 participants at risk Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.	MCV4+Tdap+Saline n=870 participants at risk Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.	Saline+Saline+rLP2086 n=875 participants at risk Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
Congenital, familial and genetic disorders Adrenogenital syndrome	0.11% 1/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Congenital, familial and genetic disorders Congenital spinal cord anomaly	0.11% 1/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Gastrointestinal disorders Pancreatitis acute	0.00% 0/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.11% 1/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Appendicitis	0.11% 1/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.11% 1/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Bone abscess	0.11% 1/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Gastroenteritis	0.11% 1/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Influenza	0.00% 0/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.11% 1/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Pneumonia	0.00% 0/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.11% 1/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Pneumonia viral	0.11% 1/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Tooth abscess	0.11% 1/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Injury, poisoning and procedural complications Concussion	0.00% 0/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.11% 1/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Injury, poisoning and procedural complications Epiphyseal fracture	0.00% 0/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.11% 1/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Injury, poisoning and procedural complications Excoriation	0.00% 0/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.11% 1/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Injury, poisoning and procedural complications Joint injury	0.00% 0/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.11% 1/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Injury, poisoning and procedural complications Radius fracture	0.11% 1/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Injury, poisoning and procedural complications Wound secretion	0.11% 1/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.11% 1/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.11% 1/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Metabolism and nutrition disorders Diabetic ketoacidosis	0.11% 1/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.11% 1/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Musculoskeletal and connective tissue disorders Bone cyst	0.00% 0/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.11% 1/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Musculoskeletal and connective tissue disorders Scoliosis	0.11% 1/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Nervous system disorders Convulsion	0.00% 0/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.11% 1/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.11% 1/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Nervous system disorders Dural arteriovenous fistula	0.11% 1/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Nervous system disorders Hemiplegic migraine	0.00% 0/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.11% 1/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Nervous system disorders Migraine	0.00% 0/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.11% 1/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Nervous system disorders Syncope	0.11% 1/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Psychiatric disorders Affective disorder	0.11% 1/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.11% 1/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Psychiatric disorders Depression suicidal	0.00% 0/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.11% 1/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Psychiatric disorders Disorientation	0.00% 0/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.11% 1/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Psychiatric disorders Encopresis	0.11% 1/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Psychiatric disorders Post-traumatic stress disorder	0.11% 1/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Psychiatric disorders Psychogenic seizure	0.11% 1/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.11% 1/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.00% 0/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.11% 1/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Vascular disorders Haemorrhage	0.11% 1/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Nervous system disorders Cerebrovascular accident	0.00% 0/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.11% 1/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).

Other adverse events
Measure	MCV4+Tdap+rLP2086 n=883 participants at risk Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.	MCV4+Tdap+Saline n=870 participants at risk Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.	Saline+Saline+rLP2086 n=875 participants at risk Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
Gastrointestinal disorders Vomiting	2.0% 18/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	2.4% 21/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	2.2% 19/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Gastrointestinal disorders Nausea	1.1% 10/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.0% 9/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.6% 14/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Gastrointestinal disorders Abdominal pain	0.23% 2/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.80% 7/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.1% 10/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
General disorders Injection site pain	2.2% 19/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	2.4% 21/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.7% 15/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
General disorders Pyrexia	2.3% 20/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.6% 14/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.9% 17/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Upper respiratory tract infection	5.3% 47/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	7.0% 61/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	8.0% 70/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Pharyngitis	4.3% 38/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	3.1% 27/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	3.2% 28/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Pharyngitis streptococcal	2.6% 23/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	2.3% 20/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	3.4% 30/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Nasopharyngitis	2.5% 22/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	2.2% 19/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.8% 16/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Gastroenteritis viral	1.7% 15/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.7% 15/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	2.9% 25/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Gastroenteritis	1.7% 15/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	2.3% 20/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.8% 16/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Sinusitis	2.0% 18/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.5% 13/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.9% 17/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Otitis media	1.9% 17/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.3% 11/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.6% 14/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Bronchitis	0.57% 5/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.69% 6/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.7% 15/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Viral infection	0.45% 4/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.80% 7/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.4% 12/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Conjunctivitis	1.0% 9/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.69% 6/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.34% 3/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Otitis externa	1.9% 17/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.3% 11/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.6% 14/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Injury, poisoning and procedural complications Fall	1.4% 12/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.5% 13/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.8% 16/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Injury, poisoning and procedural complications Ligament sprain	1.4% 12/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.4% 12/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.5% 13/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Musculoskeletal and connective tissue disorders Pain in extremity	1.0% 9/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.46% 4/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.91% 8/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	1.0% 9/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.23% 2/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.34% 3/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Nervous system disorders Headache	2.7% 24/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	3.3% 29/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	3.0% 26/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Respiratory, thoracic and mediastinal disorders Cough	2.9% 26/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	2.3% 20/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	3.5% 31/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.9% 17/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.5% 13/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	2.6% 23/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.45% 4/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.57% 5/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.3% 11/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.68% 6/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.46% 4/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.1% 10/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Respiratory, thoracic and mediastinal disorders Asthma	0.68% 6/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.46% 4/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.0% 9/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Skin and subcutaneous tissue disorders Dermatitis contact	1.2% 11/883 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.11% 1/870 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.57% 5/875 • AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination) SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).